The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Diode Trabeculoplasty Laser Dtl.
| Device ID | K910612 |
| 510k Number | K910612 |
| Device Name: | CANDELA DIODE TRABECULOPLASTY LASER DTL |
| Classification | Laser, Ophthalmic |
| Applicant | CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Contact | George Cho |
| Correspondent | George Cho CANDELA LASER CORP. 530 BOSTON POST RD. Wayland, MA 01778 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-03-04 |